California Designated Representative Training Courses (wholesaler, 3PL, reverse distributor) – Approved by the California State Board of Pharmacy “Many years ago, I worked for a very insightful CIO who mastered communications to senior executive management. Often, when he received pressure regarding systems maintenance budgets associated with mission critical business systems such as order fulfillment, he […]
Tag: DSCSA
With One Day Remaining Before July 1 Compliance Date, FDA Exercises Enforcement Discretion of DSCSA’s Product-Tracing Requirements for Dispensers – FDA Law Blog
“Only one day before the product-tracing provisions of the Drug Supply Chain Security Act (“DSCSA”) were set to take effect for dispensers, FDA issued a Guidance Document for immediate implementation that signals FDA’s intention to delay any use of enforcement for failure to comply with the DSCSA’s two major product-tracing requirements for dispensers until November […]
Wholesale Distributor & Third-Party Logistics Providers Reporting – FDA Requirement
“The Federal Food, Drug, and Cosmetic Act as amended by the DSCSA, requires third-party logistics providers to begin reporting this information annually to FDA on November 27, 2014, while wholesale distributors are required to begin on January 1, 2015. FDA has issued a draft guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and […]
FDA Announces Exercise of Enforcement Discretion on Imminent Track and Trace Requirements – FDA Law Blog
“On December 24th, in response to industry requests, FDA issued a guidance document indicating that it will not enforce product tracing requirements of the Drug Supply Chain Security Act (“DSCSA”) prior to May 2015. The guidance, states in relevant part:” . . . Read the full article: via FDA Law Blog: In Keeping With the […]
FDA > Are you ready for the Drug Supply Chain Security Act?
Become familiar with the law There are new requirements under the Drug Supply Chain Security Act (DSCSA) for manufacturers, repackagers, wholesale distributors, dispensers, and third-party logistics providers (trading partners). Some requirements began in November 2014 and several key requirements begin at various stages in 2015. The new requirements, development of standards, and the system for […]
Full-line distributor sales reached $305 billion in 2013, representing 90% of pharma sales – Pharmaceutical Commerce
“HDMA’s 2014-15 Factbook updates member financial, operational performance. The just-published 2014-15 Factbook, a compilation of HDMA member data as well as relevant industry statistics, gives evidence that full-line wholesalers are running faster—shipping more products each day, while handling a higher daily average of orders. The report also provides a snapshot of what the industry was […]